Summary:
Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on lack of education credentials for review and interview with the technical consultant, the laboratory director failed to ensure that prior to testing patients' specimens, all personnel have the appropriate education for the type and complexity of services offered. Findings include: 1. No evidence of education credentials was presented for review for one testing personnel who began patient testing on 2/08 /2022. 2. The technical consultant interviewed on 05/23/2023 at 12:20pm confirmed the laboratory failed to provide a copy of the education credentials for the testing personnel indicated above. 3. The laboratory began patient testing in the specialties of Chemistry and Hematology in October 2021, with an approximate annual test volume of 1,800. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --